Decision by US District Court!! Dismissal of patent rights over naturally-occurring alleles.

Great excitement in the CAS-IP Office this week!!!

This is a decision that could be likened to a blast of dynamite!!  A direct dismissal of patent rights over naturally-occurring alleles!!! (The specific patents of the case are the ones, held by Myriad Genetics, over BRAC1 and BRAC2 sequences and their use to test for susceptibility to breast cancer.)

From the New York Times article:

United States District Court Judge Robert W. Sweet issued the 152-page decision, which invalidated seven patents related to the genes BRCA1 and BRCA2, whose mutations have been associated with cancer.

From the decision: Page 125 of the decision:

“The preservation of this defining characteristic of DNA in its native and isolated form mandates the conclusion that the challenged composition claims are directed to unpatentable products of nature.”  (My emphasis.)  And, Page 127 of the decision: “The proper comparison is between the claimed isolated DNA and the corresponding native DNA, and the presence or absence of chromosomal proteins merely constitutes a difference in purity that cannot serve to establish subject matter patentability.”

It is also a very good piece of drafting; explaining claim interpretation, interpretation of 35 U.S.C. 101 (Inventions patentable. Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.), in addition to summarizing many other germane court decisions, etc.  The sections from pages 79-end.

You can get a copy of the decision by activating the link “152-page decision”.

This is just such great news!!!

Post written by Victoria Henson-Apollonio, PhD. Manager of CAS-IP.

One response to “Decision by US District Court!! Dismissal of patent rights over naturally-occurring alleles.

  1. Don’t break out the champagne yet! This lower court decision is quite likely to be overturned on appeal. This might eventually (many years down the road), lead to a very important supreme court case. That said, are we quite sure that on balance gene patents (to use a misleading common shorthand expression) have a negative effect on product development and producing public good? The US has the strongest patent regime in this area and the US has been by far the most effective at taking biotech products to market in both the medical and agricultural field. The current system works for new product development!

    The case in point – BRAC ‘s use as a diagnostic is a little bit of an anomaly and an outlier (in cost) as to how gene patents have been used and I understand patient outrage.

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